Knocking on Heaven’s Door: The Big Business of Lifesaving [Excerpt]

Author Katy Butler’s memoir of her family’s experience surrounding her father’s prolonged, over-medicalized final years blends personal reflection with investigative reporting on biotechnology to offer readers insights into the art of dying better

On the idealistic and hopeful day in 1958 when the forty-three-year-old Swedish ice-skater and businessman Arne Larsson was given the world’s first fully implantable pacemaker, few in the worlds of business, engineering, or medicine foresaw a time when there would be a need or a market for hundreds of thousands more. Potential customers seemed at first glance few: a handful of “blue babies” and adults emerging from pioneering heart surgeries with unintended cardiac damage, and another handful of fatally ill people like Larsson who got dizzy and fainted multiple times a day because their hearts failed to maintain normal beats.

Things were about to change. Two years after Larsson’s surgery, the pacemaker moved out of the hands of tinkerers and onto small assembly lines. By the end of December 1960, Medtronic’s cofounder Earl Bakken—who’d been persuaded by a Lutheran minister when he was a teenager to turn his inventiveness away from tasers and toward helping people and who did not even mention “profit” in his company’s original mission statement— had taken orders for fifty pacemakers, priced at $375 each.

In 1961, Bakken bought the licensing rights to a fully implantable pacemaker similar to Arne Larsson’s, designed by the American inventor Wilson Greatbatch in a converted barn behind his house in Buffalo, New York. Sales were slow at first. In 1962, Medtronic lost $144,000. The next year, when U.S. health care spending was 5.3 percent of gross domestic product (GDP), and the average American life span was close to seventy, Medtronic sold only twelve hundred pacemakers and edged barely into the black. The start-up was so starved for capital that Bakken considered selling it to the Mallory Battery Company, but the deal fell through after the Arthur D. Little consulting company estimated that only ten thousand people worldwide would ever need pacemakers. Then, in 1965, Medicare—the Great Society insurance program bitterly opposed by the American Medical Association (AMA) and championed, like the 911 system, by the heart attack survivor President Lyndon B. Johnson—was established. It approved the pacemaker for reimbursement the following year for any American over the age of sixty-five with a medical need for one, and Earl Bakken’s world changed.

In the first full year of Medicare reimbursement, when health care consumed only 5.9 percent of GDP, Medtronic sold seven thousand four hundred pacemakers, six times as many as it had three years before. It made a profit of nearly $308,000. Two years later, in 1968, it reported annual sales of $10 million and profits of more than $1 million. By 1970, health care spending was consuming 7.2 percent of GDP, and Medtronic’s annual sales had more than doubled, to $22 million. Pacemakers had become the company’s cash cow.

The atmosphere in what would later be nicknamed “Medical Alley”—Minnesota’s cluster of high-tech medical start-ups— soon rivaled that of the nascent semiconductor industry near Stanford University in northern California’s Santa Clara Valley. In small towns on the outskirts of Minneapolis and St. Paul, engineers, visionaries, and salespeople rented offices; wooed venture capitalists; invented, borrowed, and stole innovative technologies; and sued one another for patent infringement and theft of intellectual property. Members of a new breed of sales man—part electrical engineer, part medical paraprofessional, and part Willy Loman—fanned out across the country, entering operating rooms dressed in scrubs just like doctors, to show eager but ignorant physicians how to implant the new devices. Big corporations bought out small companies. Initial public offerings showcased shares that doubled in price within hours of hitting the stock market and stayed high.

Four Medtronic engineers and salesmen, frustrated with Earl Bakken’s cautious approach to technological innovation, left his company to manufacture a slimmer pacemaker also designed by Wilson Greatbatch but powered by a longer-lasting, hermetically sealed lithium battery. (The earlier models had mercury-zinc batteries, which released small amounts of hydrogen gas and lasted only a year or two before needing replacement.) The start-up, Cardiac Pacemakers, Inc., was financed with $50,000 in bank loans and $450,000 in venture capital. Its pacemaker was barely more than a prototype, and at first its salesmen had nothing to show doctors but a wooden mock-up. It had almost no sales in 1972, its first year.

Four years later, with health care now consuming 8.4 percent of GDP, and the average American life span creeping up toward seventy-three, Cardiac Pacemakers had $47 million in sales. “The profit margins were beautiful in those days,” said one of the company’s founders, Manuel Villafaña, a colorful former Medtronic salesman born in the South Bronx who’d earlier introduced Medtronic pacemakers to doctors in South America and Europe. Cardiac Pacemakers’ after-tax profits were 20 percent. Two years later, its founders sold the company to the Eli Lilly pharmaceutical company for $127 million. Renamed Guidant, it would later branch into coronary stents and other cardiac hardware and become the world’s third-largest manufacturer of cardiac-surgery devices—and would employ Katrina Bramstedt, who later became a bioethicist. In 2004, it was sold to Boston Scientific and Abbott Laboratories for $27.2 billion.

Spin-offs begat spin-offs. Manuel Villafaña left Cardiac Pacemakers to found St. Jude Medical, Inc., which developed and promoted a new heart valve made of stone-hard pyrolytic carbon, a major advance over the bulkier metal and plastic ball-and-ring models, prone to clotting, then being used by surgeons such as Dwight Harken at Peter Bent Brigham Hospital in Boston. The St. Jude valve became the most commonly used in the world; in one of its early years, after-tax profits hit 48 percent. St. Jude would use those accumulated profits a couple of decades later to buy a thriving international pacemaker company called Pacesetter, part of the German industrial and health behemoth Siemens, which had earlier swallowed Elema-Schönander, the Swedish company whose inventors saved Arne Larsson’s life.

The secret to success from the first was a guaranteed market and close-to-guaranteed prices. Unlike the tightly controlled, government-run variants of universal health care then being pioneered in many European countries, Medicare functioned more like a government-funded insurance company. Thanks to intense lobbying from the AMA, it was never given authority to negotiate bulk discounts, to request bids for standardized models, to second-guess a doctor’s decision, to control prices, or otherwise to interfere with what the AMA called the “doctor-patient relationship.” In the United States, a handful of pacemaker companies, enjoying a near monopoly, essentially set prices. Individual doctors decided independently who needed the devices and billed Medicare their “usual and customary” fees. Hospitals provided operating rooms and ancillary services, exercised little control over the doctors who used them, and billed Medicare separately. Medicare simply paid. Thanks to this unique financial structure—a griffin-like hybrid with neither the marketplace checks and balances of capitalism nor the top-down government controls of socialism—pacemakers and other emerging medical technologies were delivered practically cost-free to the hospital, surgeon, and patient. The system had no brakes.

As profits grew and sales forces expanded in Medical Alley, the thinking and practice of many cardiologists across the country changed. In its pioneering days, the pacemaker was regarded as a specialized lifesaver for a handful of otherwise healthy people with fatal disturbances in heart rhythm. After Medicare, as the devices improved technologically and inserting them became simple and profitable, the rationale changed. Doctors began inserting them to improve “quality of life” in a much larger pool of older people with minor heart arrhythmias. They next began inserting them on a “just in case” basis in relatively healthy people whose hearts were slowing down naturally with age but who had no symptoms at all. People like my father.

In 1974, a Columbia Medical School cardiologist named Irene Ferrer, a sister of the actor Mel Ferrer, argued that “periodic or sustained sinus bradycardia [that is, a slow heartbeat] can no longer go unchallenged, even if asymptomatic.” Pacemakers, she said, should be implanted on a “prophylactic” [preventive] basis, particularly in patients in a broad new diagnostic category called “sick sinus syndrome,” characterized by a variety of modest disturbances in the heart rhythm revealing themselves on newer, ever-more-sensitive diagnostic machines. Pacemaker implantations doubled year by year. The guiding principles of the day were maximum promotion and maximum treatment.

Behind the scenes, meanwhile, Medicare—which paid for about 85 percent of pacemaker insertions and thus was primarily responsible for the explosive growth of the industry—was changing the shape of American medicine. Medicare’s framers had hoped to provide better medical care for the elderly. They did. The average life span increased from sixty-five in 1940 to seventy-one in 1970. Deaths from heart disease fell. But because Medicare mimicked the fee-for-service structure of existing private insurance plans, it paid better for procedures than for time. It starved doctors who provided hands-on primary care and overrewarded specialists who churned out procedures. Pay for primary care doctors was so poor that some of them refused to take Medicare patients at all. Doctors peddled their wares on a piecework basis; communication among them became haphazard; thinking was often short-term; nobody made money when medical interventions were declined; and nobody was in charge except the marketplace.

Fueled not only by Medicare but also by private health insurance, doctors’ average incomes quintupled—from $50,000 a year in 1940 in 2011 dollars to nearly $250,000 in 1970. Most of the increase went to specialists. Doctors flocked to where the money was: by 1969, there were nearly three specialists for each primary care doctor in America. When Medicare approved coverage for routine colonoscopies, gastroenterology incomes rose, and so did the number of gastroenterologists.

Newly enlarged high-rise hospitals—technological palaces fueled by private insurance and by federal dollars for research, construction, and patient care—were built in cities across the country. In their shadows often lay neighborhoods of the impoverished and the working poor, served, if at all, by a dwindling pool of underpaid and low-status internists and family doctors who maintained close emotional relationships with their patients throughout their lifetimes. Among those who suffered most, along with the poor, were the chronically ill and elderly of all classes: those with problems that couldn’t be fixed, who most needed the soft technologies of thoughtful, old-fashioned doctoring; advice on lifestyle and adaptation; and the time-consuming hands-on attention of a general practitioner. Despite the best intentions of its framers, Medicare’s payment structure punished doctors who practiced the Slow Medicine the elderly often needed and rewarded those on the hard-tech cutting edge.

Cardiac hypermarketing, meanwhile, grew so outrageous that it drew attention outside the hermetically sealed worlds of the operating room and Medical Alley. In what turned out to be the first of repeating waves of scandals similar to those in the pharmaceutical industry, witnesses told a Senate subcommittee in 1981 that some doctors were deliberately performing unnecessary pacemaker implantations in return for device industry kickbacks. Sales reps at one pacemaker company—a company, as it happened, with a terrible product-safety record—gave their most “productive” doctors free stays at the company hunting lodge and on the company yacht. Others hired the comedian George Burns and the cheerleaders for the Dallas Cowboys to regale doctors at free dinners and parties. “In all my twenty years experience in the medical sales field, I have never seen a business so dirty, so immensely profitable, and so absent normal competitive price controls as this one,” one former salesman told the Senate subcommittee.

The subcommittee issued a tough report entitled “Fraud, Waste and Abuse in the Medicare Pacemaker Industry.” The FBI investigated. Medicare drastically revamped its payment system in an attempt to get a handle on costs. In 1983, several executives of Siemens-Pacesetter, Inc. (the pacemaker company later acquired by St. Jude, which made my father’s pacemaker) pled guilty and its former CEO pled nolo contendere to federal charges that they’d paid kickbacks to doctors for implanting pacemakers. They were given suspended sentences and fined.

Some troubled cardiologists—often those paid salaries by universities rather than earning a living in private practice—had growing doubts about where the whole enterprise was leading. At a cardiology conference in Manhattan devoted to the elimination of fatal heart attacks, Henry Greenberg, the director of a hospital coronary care unit, delivered a contrarian and prescient paper called “In Praise of Sudden Death.” He’d informally polled his cardiologist friends and their families, he said, and “not one wished anything but a sudden, unexpected exit while in the pink of health. There were not even any votes for a classic death-bed scene, with the family gathered.” The preferred age for this death, he said, was around eighty. “We all want to live to the fullest extent of our capacity as a sapient being capable of joy and delight, but at the proper time life can be quickly and gently rounded with a sleep,” he told his cardiology colleagues in 1982:

What if we are fully successful in the purpose of our gathering? Will we devoutly wish for a new risk factor to call into play as we see memory slipping as our dotage arises? Will we avoid physicians and hospitals for routine ailments because we are afraid that unacceptable illnesses will be prolonged interminably?

In the aftermath of the pacemaker scandal, a committee appointed by the American College of Cardiology wrote a set of clinical guidelines in 1984 intended to discourage overtreatment. On a logic that boiled down to “if it ain’t broke, don’t fix it,” the committee advised against implanting the devices in patients with no troubling physical symptoms and no sign of dis- ease beyond slightly irregular cardiograms, slow heartbeats, or vague diagnoses such as sick sinus syndrome. Over the next five years, pacemaker implantations in Medicare patients dropped by 25 percent. But the basic pattern—maximum promotion, the creeping expansion of diagnoses for which pacemakers and other cardiac devices were supposedly warranted, disguised gratuities to cardiologists, and cat-and-mouse games with Medicare—did not end. No matter how Medicare tried to change its rules and tighten the spigot, money continued to flood into the device companies, and like water seeking its own level, some of that money trickled down to cardiologists. By 1987, the median income of cardiovascular surgeons was $271,555, while most primary care doctors earned considerably less than $100,000.

One former Medtronic sales rep told me that in the 1980s he was sent to a three-day course in fine wines, all the better to wine, dine, and knowledgeably converse with the upscale cardiologists who were his sales prospects. In the early 1990s, one of pacemaking’s pioneers, a respected university-based cardiac surgeon, saw how far things had gone wrong when he flew from the east coast to Los Angeles to supervise the placement of a pacemaker in his mother-in-law, who was then in her early nine- ties. “I went out there on a Saturday to Cedars Sinai, I guess in February,” said the east coast surgeon, who asked to remain anonymous. “It was a very quiet day, and the surgeon and I were sort of waiting around. It turned out we were waiting for the sales rep, and finally he arrived. The doctor put in the pace- maker adequately, and the sales rep handed the surgeon a pack-age and left. The surgeon opened it in front of me, seemingly not at all embarrassed; it was a nice gold wristwatch, as a present.”

Time passed. Things changed. Things stayed the same. The number of transistors in a typical pacemaker grew from only two to more than four million. U.S. health care costs kept rising, to nearly double those in some European countries, without a corresponding gain in health. In 2003, the year my father got his device, when health care was consuming 15.9 percent of GDP and the average American life span had risen to seventy-seven, a Medicare study found that medical device companies were enjoying average net profit margins of nearly 20 percent. It was, the New York Times pointed out, more than twice the average for all other companies in the S&P 500. Cardiac surgery was so profitable that many hospitals relied on it to subsidize their emergency rooms and other money-losing departments and ran full-page ads in major newspapers to attract new customers. Cardiologists published a flurry of journal articles about successful surgeries in patients over eighty and over ninety. Device-related heart surgeries alone in 2003 cost Medicare nearly $15 billion.

By then, there were all kinds of devices: stents, little cage-like tubes to prop open clogged arteries; drug-coated stents, less prone to clogging than bare metal ones; external heart pumps like the one that would later be attached to former Vice President Dick Cheney, each one costing Medicare more than $500,000. There were chemically pickled and sterilized heart valves taken from human cadavers and from pigs, and delicate bionic valves hand sewn in Southern California factories by Vietnamese-American and Cambodian-American women working with the sterilized heart tissue of cows.

In May 2003, Michael N. Weinstein, a senior analyst at J.P. Morgan, called the cardiac device business “an area of tremendous interest.” Medical devices of all sorts had become a $170 billion global industry, and cardiac devices alone generated $14 billion in worldwide sales. Weinstein’s “top pick,” he told an interviewer for the New York Times’s Market Insight column, “is St. Jude Medical. They are a play on the cardiac rhythm market.”

The market was not pleased, however, in the spring of 2006 when Medicare proposed yet another change in the formulas under which it reimbursed hospitals, in hopes of reducing payments for implanted devices and raising payments for under- compensated services like stroke care. Payments for pacemaker surgeries were expected to drop by about 13 percent, defibrillators by 25 percent, and stents by 33 percent. AdvaMed, the device industry’s primary voice in Washington, pushed back. In April, AdvaMed hired two former health care staffers from the House Ways and Means Committee and another who’d once worked in health policy for Senator Ted Kennedy.

Over the next few months, AdvaMed spent $1 million on what its chief called “inside the Beltway advertising and extensive media outreach, ‘grass tops’ advocacy efforts, and intense lobbying of key House and Senate Members.” It created a photo exhibit on Capitol Hill featuring enthusiastic patients such as Reagan administration official Michael Deaver, who had an artificial knee; former Olympic skater Bonnie Blair, who’d benefited from an implanted anti-incontinence surgical device; and a former NBA basketball player who had a pacemaker. It held a press conference featuring the heads of two nonprofit, apparently grassroots, groups—the Sudden Cardiac Arrest Association, a defibrillator-promoting group funded mainly by the cardiac device industry; and the Society for Women’s Health Research, which got most of its grants from big medical players, including the Medtronic Foundation and Boston Scientific.

What went unremarked was the eternal background music of Washington. The makers of pharmaceuticals and medical supplies constitute one of the capital’s three biggest lobbies, rivaling the defense industry and Wall Street. In 2006, AdvaMed, the Big Three pacemaker companies, and other medical technology and supply companies spent at least $27 million on lobbying Medicare, the Food and Drug Administration, Congress, and other parts of the federal government. They contributed another $1.5 million to federal political campaigns.

The money and attention were well spent. After two hundred members of the House and Senate from both parties wrote to Medicare questioning the proposed cutbacks, its top administrator, Mark McClellan, said he had taken the objections “to heart” and essentially gutted the plan, making changes that in the estimation of AdvaMed, recaptured $3 billion in at-risk sales revenues. Shares of Medtronic, St. Jude Medical, and Boston Scientific rose on the news.

Business as usual continued, and money continued to flow and drip from device companies to cardiologists. In 2007—the year that my father forgot the purpose of his dinner napkin—a registered nurse named Charles Donigian resigned from his job in the regional sales office of St. Jude Medical in St. Louis, Missouri, where he’d helped administer follow-up surveys of patients who’d been given pacemakers and defibrillators. Donigian said he resigned because he thought he’d soon be fired for refusing to bend ethical rules. He subsequently filed a lawsuit seeking damages under the federal law that protects whistle- blowers.

In his suit, which the Justice Department later joined, Donigian said that St. Jude had essentially paid kickbacks to doctors who chose its products, in the form of what he called “sham fees for phony postmarket clinical research studies.” In one study, St. Jude paid the doctors $2,000 per enrolled patient. The doc-tors mainly provided the names, Donigian claimed, while he and others at St. Jude did the paperwork as well as the doctors’ Medicare billings.

St. Jude salesmen also gifted doctors with fishing trips to Canada, tickets to St. Louis Cardinals games, airline tickets to Las Vegas, and dinners at steak houses, Donigian said. One sales representative, he said, had an expense account of $250,000 a year, mainly to entertain and reward cardiologists. The corruption went both ways: one cardiac catheterization lab, he claimed, told St. Jude sales reps they expected a catered lunch for the entire office each time they implanted a St. Jude product.

Donigian said that St. Jude employees ghostwrote two research presentations summarizing the results of one cardiac follow-up study (the RARE trial), and paid one of the doctors named as a lead investigator to travel to the annual meeting of the Heart Rhythm Society, the cardiac device specialist’s group, and present the findings in a scientific poster session in the exhibit hall as if they were his own.

Donigian said that St. Jude planned to spend $158 million on educational and career guidance programs for “fellows,” young cardiologists training in electrophysiology, the subspecialty that manages cardiac devices. An internal marketing document estimated that each of the one hundred fellows who became a full-fledged electrophysiologist and conservatively prescribed St. Jude products could generate $2.7 million in device sales a year. After the Justice Department joined the case, St. Jude, without admitting wrongdoing, settled the lawsuit in early 2011 for $16 million, of which Donigian received $2.6 million. The Code of Business Conduct on the St. Jude Web site states that sales- people’s gifts to doctors should not be “extravagant” or “beyond that which is customary,” but those terms are not defined.

In 2008, a year after Donigian quit, the American College of Cardiology, the Heart Rhythm Society, and the American Heart Association issued the latest update of their treatment guidelines for pacemakers. The list of diagnoses for which they were strongly or mildly recommended had grown since the guidelines were first issued in 1984. The 1984 guidelines recommended pacemakers for fifty-six heart conditions. The 2008 guidelines recommended them for eighty-eight. The research backing the expansion was weak, with only 5 percent of the positive recommendations backed by medical research’s “gold standard”: multiple randomized double-blind studies. Most were based only on a consensus of “expert opinion.” Of the seventeen cardiologists who wrote the 2008 guidelines, eleven received financing from cardiac-device makers or worked at institutions receiving it. Seven, due to the extent of their financial connections, were recused from voting on the guidelines they helped write.

This pattern—a paucity of scientific support and a plethora of industry connections—held across almost all cardiac treatment guidelines, said cardiologist Pierluigi Tricoci of Duke University and his coauthors in an article published in 2009 in the Journal of the American Medical Association. “Experts are as vulnerable to conflicts of interest as researchers are,” they wrote, and added that the current cardiac-research agenda was “strongly influenced by industry’s natural desire to introduce new products.”

That desire would be on full display in the spring of 2011, two years after my father’s death, when I parked in a municipal parking garage on Mission Street near the San Francisco Chronicle, my old newspaper, and walked toward the Moscone Convention Center, where the Heart Rhythm Society was holding its annual conference. It was a sunny, windy day in the South of Market district. The first thing that caught my eye was a fleet of black motorcycles repeatedly circling the block, each one towing a shiny black minitrailer bearing the logo of St. Jude Medical (“More Control! Less Risk!”). Towering above me on the side of a two-story building were five orange, turquoise, blue, and purple billboards, each bigger than a movie marquee, trumpeting the behemoth Medtronic’s implantable cardiac defibrillators (“Fewer Shocks! MRI Access!”), its surgical tools for a heart procedure called cardiac ablation (“Inflation/Ablation!”), and its corporate logo (“Innovating for Life!”). A commercial white stretch limousine idled by the curbside, trolling for customers.

Outside the convention center, the sides of official shuttle buses were covered with company logos. Inside the hall were more logos—for Biosense, Johnson & Johnson, Siemens, Zoll, and Greatbatch—plastered on water coolers, on piles of complimentary tourist maps of San Francisco, on Internet access booths, and above laptop charging stations. A sign above the couches of the Infinity Circle where tired cardiologists checked their e-mail read, “Year Round Support: Infinite Gratitude: Heart Rhythm Society,” followed by a list of its top corporate contributors, including Medtronic, Boston Scientific, St. Jude Medical, and Sanofi Aventis (“Because Health Matters”). All told, medical technology companies paid the Heart Rhythm Society $5.1 million—nearly a third of its $16.8 million annual budget—to rent exhibit booths and otherwise promote themselves to the more than three thousand physicians attending the four-day convention. This was the sea in which cardiologists swam.

St. Jude Medical, the maker of my father’s device and the conference’s third-biggest spender, paid $653,000, including $15,000 for ads on the risers of stairs, $45,000 for the privilege of hosting complimentary dinner seminars and other educational events for doctors in hotel banquet rooms, $55,000 to hang banners above stairways, $70,000 to put its logo on the cardiologists’ hotel key cards, and $308,000 for exhibit booth space on the showroom floor. The company was on Fortune’s list of the world’s most admired companies. It employed about thirteen hundred sales representatives and was a member of the Fortune 500, with a market capitalization of $13 billion.

Wearing my press badge and carrying the complimentary tote bag I was handed in the well-stocked press room, I walked into Moscone’s huge underground commercial exhibit hall. It reminded me of a combination of a carnival midway, an auto showroom, and the largest Apple store on earth. Everywhere I looked, flat-screens glowed and pulsed, displaying loops of medical-technology advertising. The average American life span was now seventy-eight and a half, and health care was consuming 17.9 percent of America’s GDP per year. Salesmen and saleswomen with expensive haircuts circled clutches of slim, vital doctors in sharp dark suits. Suspended above our heads in the hangar-like space were gigantic plastic signboards in whites and cool blues and greens, reading, “St. Jude Medical,” “Medtronic,” and “Biotronik: Excellence for Life.”

A kind and handsome sales engineer at the St. Jude Medical booth—it wasn’t a booth, really, it was at least four times the size of my living room—handed me a pacemaker much like the one Dr. Aranow had tucked into the pocket of skin beneath my late father’s collarbone years before. It was flattish, roughly ovoid and encased in titanium, the color of dull silver. About the size of a pocket watch, it looked a little like a silver dollar that had been flattened on a railroad track. “St. Jude Medical, TM,” was engraved on its side, along with the location of the factory where it was made: Sylmar, California. It fit into my palm.

I closed my hand around the tiny little machine that had saved many a life, made many a fortune, and led my family to so much unnecessary suffering.